AccessGUDID - DEVICE: Aperio AT2 DX Scanner (00815477020259)

GUDID

Device Identifier (DI) Information

Brand Name: Aperio AT2 DX Scanner
Version or Model: 23AT2DX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LEICA BIOSYSTEMS IMAGING, INC

Primary DI Number: 00815477020259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063440460 *Terms of Use

Device Description: Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61927	Multi-modality clinical specimen analysis system IVD	An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PSY	Whole slide imaging system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190332	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: f254dbb2-1408-4001-a4f5-ac020c65b47e
Public Version Date: January 31, 2020
Public Version Number: 1
DI Record Publish Date: January 23, 2020